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Clinical Effectiveness of Regdanvimab Treatment for Mild-to-Moderate COVID-19: A Retrospective Cohort Study

Jang et al., Current Therapeutic Research, doi:10.1016/j.curtheres.2022.100675
May 2022  
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Oxygen therapy 60% Improvement Relative Risk Discharge, day 14 44% Discharge, day 11 35% Hospitalization time 13% Regdanvimab for COVID-19  Jang et al.  EARLY TREATMENT Is early treatment with regdanvimab beneficial for COVID-19? Retrospective 210 patients in South Korea (September 2020 - July 2021) Lower need for oxygen therapy (p<0.0001) and higher discharge (p=0.025) c19early.org Jang et al., Current Therapeutic Resea.., May 2022 Favorsregdanvimab Favorscontrol 0 0.5 1 1.5 2+
35th treatment shown to reduce risk in March 2022, now with p < 0.00000000001 from 11 studies, recognized in 27 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 109 treatments. c19early.org
Retrospective 317 hospitalized mild-moderate COVID-19 patients in South Korea showing significantly lower rates of oxygen desaturation (SpO2 <94%) at 28 days (primary outcome) with regdanvimab monoclonal antibody treatment (13%) compared to standard of care (40%). Regdanvimab also showed benefits in time to fever recovery, discharge rates, and supplemental oxygen use.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2, BA.4, BA.51, ХВВ.1.9.1, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.12.
risk of oxygen therapy, 59.6% lower, RR 0.40, p < 0.001, treatment 17 of 73 (23.3%), control 79 of 137 (57.7%), NNT 2.9.
risk of no hospital discharge, 44.1% lower, RR 0.56, p = 0.03, treatment 14 of 73 (19.2%), control 47 of 137 (34.3%), NNT 6.6, day 14.
risk of no hospital discharge, 34.9% lower, RR 0.65, p < 0.001, treatment 34 of 73 (46.6%), control 98 of 137 (71.5%), NNT 4.0, day 11.
hospitalization time, 12.9% lower, relative time 0.87, p = 0.003, treatment mean 12.1 (±4.0) n=73, control mean 13.9 (±4.3) n=137.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Jang et al., 16 May 2022, retrospective, South Korea, peer-reviewed, 3 authors, study period September 2020 - July 2021. Contact: kjykey@icmc.or.kr.
This PaperRegdanvimabAll
Clinical Effectiveness of Regdanvimab Treatment for Mild-to-Moderate COVID-19: A Retrospective Cohort Study
MD Young Rock Jang, MD Yoon Ju Oh, MD, MPH Jin Yong Kim
Current Therapeutic Research, doi:10.1016/j.curtheres.2022.100675
Background: In a Phase III study, regdanvimab (CT-P59) reduced the risk of hospitalization or death versus placebo in patients with mild-to-moderate coronavirus disease 2019 (COVID-19). Purpose: We performed a retrospective cohort study of patients with COVID-19 to examine the effect of regdanvimab versus standard of care (SoC) on oxygen saturation. Methods: We reviewed patients with mild-to-moderate COVID-19 confirmed by reverse transcriptionpolymerase chain reaction at a single hospital in the Republic of Korea. The primary efficacy end point was the proportion of patients deteriorating with peripheral capillary oxygen saturation < 94% on room air up to day 28. Results: A total of 127 patients were treated for COVID-19 with regdanvimab, 190 with SoC. The proportion of patients deteriorating with peripheral capillary oxygen saturation < 94% on room air up to day 28 was 13.4% with regdanvimab and 39.5% with SoC ( P < 0.0 0 01); median time (range) until sustained recovery of fever was 2.0 (0.2-14.8) and 4.2 (0.1-17.1) days, respectively. Supplemental oxygen was required by 23.6% of patients with regdanvimab and 52.1% with SoC ( P < 0.0 0 01) for a mean of 6.3 and 8.7 days, respectively ( P = 0.0113); no patients needed mechanical ventilation. Compared with SoC, hospitalization was shorter with regdanvimab (mean = 11.1 vs 13.6 days; 63.8% vs 31.6% discharged within 11 days; both P values < 0.0 0 01). Fewer regdanvimab-treated patients required remdesivir (14.2% vs 43.2%; P < 0.0 0 01). There were no deaths. Two patients had adverse reactions with regdanvimab. Conclusions: This real-world study indicates that regdanvimab can prevent deterioration in patients with mild-to-moderate COVID-19. (
Conflicts of Interest Statement The authors have indicated that they have no conflicts of interest regarding the content of this article.
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